Home / Recalls / Hospira Inc., A Pfizer Company / D-0218-2017

D-0218-2017 Class I Ongoing

Recalled by Hospira Inc., A Pfizer Company — Lake Forest, IL

FDA drug recall D-0218-2017 was initiated by Hospira Inc., A Pfizer Company on Aug 4, 2016 and is designated Class I. Reason for recall: Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial. The recall status is ongoing. Affected quantity: 143,250 vials.

Recall details

Product Type: Drugs
Report Date: Dec 28, 2016
Initiation Date: Aug 4, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 143,250 vials

Product description

Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02

Reason for recall

Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

Distribution pattern

Nationwide

Code information

Lot # 59064DK, Exp. 11/17

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0218-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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